Remote Early Clinical Scientist - Phase I Trial Leadership

Parexel; Honolulu (HI); Remote; USD 110,000 - 170,000; Full time

Job summary

Parexel is seeking an Early Clinical Scientist to coordinate design, planning and execution of early phase trials with the Clinical Director. You will oversee trials across programs and ensure excellence in execution and data validity, managing internal and external teams to meet objectives.

The role requires strong knowledge of GCP/ICH guidelines, risk management, and the ability to collaborate with regulatory, data, and operations partners across therapeutic areas.

Qualifications

• Experience managing CROs from the Sponsor side for Ph1 clinical trials.
• Use of Clinical Trial Management and Trial Master File systems.
• Authoring Protocol Concepts.
• Facilitating a Trial Team including cross functional partners such as regulatory, clinical supplies managers, data managers, statisticians, programmers, procurement, etc.
• Managing multiple projects at a time.
• Reviewing the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations.
• Working in Microsoft Teams.
• Understanding of clinical research development process from program planning to regulatory submission.
• Able to quickly develop a working scientific knowledge of different therapeutic areas.
• Ability to manage complex operations and projects under accelerated timelines.
• Scientific, medical and/or safety writing and reporting (at least one is required).
• Ability to partner effectively with internal and external teams to achieve results.
• Strong team collaboration, leadership, communication (written & verbal), issue identification and resolution skills.
• Knowledge of GCP, ICH guidelines and regulatory requirements.

Responsibilities

• Coordinate design, planning and execution of early phase trials with the Clinical Director and team.
• Oversee trials across programs/therapeutic areas to ensure excellence and data validity.
• Manage internal/external team performance and resolve project issues.
• Ensure appropriate clinical safety assessment and risk management of compounds.
• Provide real-time oversight to identify and mitigate issues in ongoing trials.
• Review and interpret clinical trial data.
• May conduct on-site monitoring, site training and supervision of complex endpoints/biomarkers.
• Apply knowledge of GCP, ICH guidelines and regulatory requirements.

Skills

CRO management

Ph1 trials

Trial Master File

Protocol concepts

Trial team facilitation

Multi-project management

Document review (protocol/IB/CSR)

Microsoft Teams

GCP/ICH knowledge

Cross-functional collaboration

Scientific writing

Data review & interpretation

Education

Life Sciences Degree

Bachelor's degree + 7+ years

Master's degree +5+ years

PhD or Doctorate +1 year

Job description

Parexel is seeking an Early Clinical Scientist to coordinate design, planning and execution of early phase trials with the Clinical Director. You will oversee trials across programs and ensure excellence in execution and data validity, managing internal and external teams to meet objectives.

The role requires strong knowledge of GCP/ICH guidelines, risk management, and the ability to collaborate with regulatory, data, and operations partners across therapeutic areas.